Trial to Assess Chelation Therapy in Critical Limb Ischemia

Phase 3

Recruiting

• Conditions: Diabetes; Critical Limb Ischemia

• Registration Number: NCT03982693
• Lead Sponsor: Mt. Sinai Medical Center, Miami

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-5-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria:<br><br> - Age = 50 years<br><br> - History of diabetes, defined as medical record evidence or patient report of<br> currently using insulin or oral hypoglycemic agents, or with a history of fasting<br> blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or<br> higher.<br><br> - Significant stenosis (= 75%) of two or more infra-popliteal arteries in the affected<br> limb as verified by at least one imaging technique (angiography, magnetic resonance<br> angiogram, coronary computed tomography angiogram, or doppler examination) within 6<br> months prior to enrollment;<br><br> - History of CLI defined as moderate or high-risk infra-popliteal chronic critical<br> limb ischemia (Rutherford Clinical Severity Score 4 or 5) defined as:<br><br> - The presence of rest pain or non-healing ulceration or gangrene for at least 2<br> weeks plus documentation of severely compromised tissue perfusion:<br><br> - If there is tissue loss, a resting ankle systolic pressure of = 60 mmHg in the<br> affected limb; or a resting toe systolic pressure of = 40 mmHg or a tissue<br> perfusion pressure (TPP) <40 mmHg.<br><br> - If there is no tissue loss, a resting ankle pressure of = 50 mmHg or resting<br> toe systolic pressure of = 30 mmHg or a tissue perfusion pressure (TPP) < 30<br> mmHg.<br><br> - Not a candidate or a failed candidate for surgical or transcatheter<br> revascularization;<br><br> - Able to give informed consent.<br><br>Exclusion Criteria:<br><br> - <7 days following lower extremity (infra-popliteal), carotid, or coronary<br> revascularization.<br><br> - Arterial insufficiency in the lower extremity as the result of a non-atherosclerotic<br> disorder.<br><br> - Subjects with evidence of active infection (e.g., cellulitis, osteomyelitis) or deep<br> ulceration exposing bone or tendon or extensive heel ulceration<br><br> - Subjects with extensive gangrene extending above the MT joint<br><br> - Subjects in whom there is severe pain at rest uncontrollable with pain medications<br><br> - Prior intravenous chelation therapy consisting of > 1 infusion within 5 years; if<br> only 1 infusion took place, patient cannot be enrolled for at least 12 months after<br> said infusion.<br><br> - Oral chelation with an FDA-approved chelating agent within 2 years<br><br> - Allergy to any components of the study drug<br><br> - Planned leg revascularization within 1 month of enrollment<br><br> - Symptomatic or clinically evident acute heart failure<br><br> - Heart failure hospitalization within 3 months<br><br> - Blood pressure >160/100<br><br> - No venous access<br><br> - eGFR < 30 mL/min per 1.73 m2 or lower (CKD stages 1-3) calculated with MDRD<br><br> - Known or suspected acute kidney injury using prevalent KDIGO criteria45<br><br> - Platelet count <100,000/mm3<br><br> - Cigarette smoking within the last 3 months<br><br> - Liver disease or Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ><br> 2.0 times the upper limit of normal (this will require clearance by the Study PI)<br><br> - Diseases of copper, iron, or calcium metabolism (other than osteopenia or<br> osteoporosis, or simple iron deficiency). These require evaluation by the Study PI<br><br> - Inability to tolerate the study-required fluid load<br><br> - Other medical condition likely to affect patient survival within 3 years<br><br> - Women of child-bearing potential<br><br> - Any factor that suggests that the potential participant will not be able to adhere<br> to the protocol.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention of major cardiovascular endpoints

Secondary Outcome Measures

Name	Time	Method
Amputations;Heart failure;Changes in Pain severity;Urine Metals;Changes in Quality of Life;Wound Severity;Changes in skin perfusion pressure in the ankle;Changes in skin perfusion pressure in the toe;Changes in PAD Quality of Life